Trial · NCT02064868
Effect of Serelaxin Versus Standard of Care in Acute Heart Failure (AHF) Patients
NCT02064868, Phase 3, Terminated, Novartis Pharmaceuticals; results first posted 2019-03-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Effect of Serelaxin Versus Standard of Care in Acute Heart Failure (AHF) Patients. Trials, record NCT02064868. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02064868
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of Serelaxin Versus Standard of Care in Acute Heart Failure (AHF) Patients
- NCT number
- NCT02064868
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 2,666 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Acute Heart Failure (AHF)
- Interventions
- Serelaxin, Standard of Care
- First posted
- 2014-02-17
- Last updated
- 2019-03-22
- Other registries' IDs
- eudract:2013-002513-35
- Results first posted
- 2019-03-22
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Worsening Heart Failure (WHF) / All Cause of Deaths Through Day 5 | 5 days | In-hospital WHF through Day 5 post-randomization included worsening signs and/or symptoms of heart failure that required an intensification of intravenous therapy for heart failure or mechanical ventilation, renal or circulatory support. A central event adjudication committee was appointed to oversee the WHF primary endpoint adjudication. |
| Secondary | Percentage of Participants With In-hospital Worsening Heart Failure/All-Cause Death/Readmission for Heart Failure Through Day 14 | 14 days | WHF/death/readmission for heart failure through Day 14. WHF/deaths through Day 5 were adjudicated and confirmed by the Clinical Endpoint Committee, WHF/deaths after Day 5 through Day 14 and readmission through Day 14 were as reported by the investigators. |
| Secondary | Percentage of Participants With Persistent Sign or Symptoms of Heart Failure / Non-Improvement at Any Post Baseline Visit Through Day 5 | 5 days | Persistent or non-improvement in any signs or symptoms of HF at any post baseline visit up to Day 5. |
| Secondary | Percentage of Participants With Renal Deterioration at Any Post Baseline Visit Through Day 14 | 14 days | Renal deterioration is defined as \> or = 0.3 mg/dL increase from screening in serum creatinine. |
| Secondary | Length of Index Hospital Stay | 30 Days | Length of stay (in hours) is defined as the index hospitalization discharge date and time minus the index hospitalization start date and time. |
| Secondary | Percentage of Participants With Adverse Events as Assessment of Safety and Tolerability of Serelaxin in AHF Patients | Adverse Events (AE): 5 Days / Serious Adverse Events (SAE): 14 days / All cause deaths 30 days | |
| Secondary | Change From Baseline in Health-related Quality of Life Index Value, Assessed by EuroQoL EQ-5D-5L Questionnaire. | Baseline, Day 5, Day 14 | EQ-5D-5L is a questionnaire designed to assess health status in adults consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). The results were converted into a single index value using UK as the reference country for all countries. Range -0.3 (worst possible state) to 1 (best possible state). |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Worsening Heart Failure (WHF) / All Cause of Deaths Through Day 5 | 5 days | Full Analysis Set | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With In-hospital Worsening Heart Failure/All-Cause Death/Readmission for Heart Failure Through Day 14 | 14 days | Full Analysis Set | Percentage of Patients | NUMBER |
| SECONDARY | Percentage of Participants With Persistent Sign or Symptoms of Heart Failure / Non-Improvement at Any Post Baseline Visit Through Day 5 | 5 days | Full Analysis Set (only evaluable patients with non-missing information included) | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Renal Deterioration at Any Post Baseline Visit Through Day 14 | 14 days | Full Analysis Set (only evaluable patients with non-missing information included) | Percentage of Participants | NUMBER |
| SECONDARY | Length of Index Hospital Stay | 30 Days | Full Analysis Set | hours | MEAN |
| SECONDARY | Percentage of Participants With Adverse Events as Assessment of Safety and Tolerability of Serelaxin in AHF Patients | Adverse Events (AE): 5 Days / Serious Adverse Events (SAE): 14 days / All cause deaths 30 days | Safety Set | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Health-related Quality of Life Index Value, Assessed by EuroQoL EQ-5D-5L Questionnaire. | Baseline, Day 5, Day 14 | Full Analysis Set (only evaluable patients with non-missing information included) | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Worsening Heart Failure (WHF) / All Cause of Deaths Through Day 5 | Serelaxin + Standard of Care | 4.95 | Percentage of Participants | ||
| Percentage of Participants With Worsening Heart Failure (WHF) / All Cause of Deaths Through Day 5 | Standard of Care (SOC) | 6.94 | Percentage of Participants | ||
| Percentage of Participants With In-hospital Worsening Heart Failure/All-Cause Death/Readmission for Heart Failure Through Day 14 | Serelaxin + Standard of Care | 8.49 | Percentage of Patients | ||
| Percentage of Participants With In-hospital Worsening Heart Failure/All-Cause Death/Readmission for Heart Failure Through Day 14 | Standard of Care (SOC) | 10.63 | Percentage of Patients | ||
| Percentage of Participants With Persistent Sign or Symptoms of Heart Failure / Non-Improvement at Any Post Baseline Visit Through Day 5 | Serelaxin + Standard of Care | 86 | 95% Confidence Interval 84 to 87 | Percentage of Participants | |
| Percentage of Participants With Persistent Sign or Symptoms of Heart Failure / Non-Improvement at Any Post Baseline Visit Through Day 5 | Standard of Care (SOC) | 91 | 95% Confidence Interval 89 to 93 | Percentage of Participants | |
| Percentage of Participants With Renal Deterioration at Any Post Baseline Visit Through Day 14 | Serelaxin + Standard of Care | 36 | 95% Confidence Interval 34 to 38 | Percentage of Participants | |
| Percentage of Participants With Renal Deterioration at Any Post Baseline Visit Through Day 14 | Standard of Care (SOC) | 44 | 95% Confidence Interval 40 to 47 | Percentage of Participants | |
| Length of Index Hospital Stay | Serelaxin + Standard of Care | 251.28 | Standard Deviation 162.368 | hours | |
| Length of Index Hospital Stay | Standard of Care (SOC) | 243.59 | Standard Deviation 160.270 | hours |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Serelaxin + Standard of Care | 1,756 | |
| Overall Study | STARTED | Standard of Care (SOC) | 894 | |
| Overall Study | Full Analysis Set | Serelaxin + Standard of Care | 1,756 | |
| Overall Study | Full Analysis Set | Standard of Care (SOC) | 894 | |
| Overall Study | Safety Set | Serelaxin + Standard of Care | 1,729 | |
| Overall Study | Safety Set | Standard of Care (SOC) | 894 | |
| Overall Study | Per Protocol Set | Serelaxin + Standard of Care | 1,155 | |
| Overall Study | Per Protocol Set | Standard of Care (SOC) | 627 | |
| Overall Study | COMPLETED | Serelaxin + Standard of Care | 1,722 | |
| Overall Study | COMPLETED | Standard of Care (SOC) | 881 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events416
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Serelaxin + Standard of Care | 49 | 1,729 | |
| other | Anaemia | Blood and lymphatic system disorders | Standard of Care (SOC) | 9 | 894 | |
| other | Atrial fibrillation | Cardiac disorders | Serelaxin + Standard of Care | 34 | 1,729 | |
| other | Atrial fibrillation | Cardiac disorders | Standard of Care (SOC) | 23 | 894 | |
| other | Cardiac failure | Cardiac disorders | Serelaxin + Standard of Care | 81 | 1,729 | |
| other | Cardiac failure | Cardiac disorders | Standard of Care (SOC) | 56 | 894 | |
| other | Mitral valve incompetence | Cardiac disorders | Serelaxin + Standard of Care | 28 | 1,729 | |
| other | Mitral valve incompetence | Cardiac disorders | Standard of Care (SOC) | 12 | 894 | |
| other | Constipation | Gastrointestinal disorders | Serelaxin + Standard of Care | 74 | 1,729 | |
| other | Constipation | Gastrointestinal disorders | Standard of Care (SOC) | 32 | 894 |
1 to 10 of 416Source ClinicalTrials.gov
See all 416 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Serelaxin + Standard of Care | 63 | 1,729 |
| Total, all-cause mortality | Standard of Care (SOC) | 43 | 894 |
| Total, other adverse events | Serelaxin + Standard of Care | 637 | 1,729 |
| Total, other adverse events | Standard of Care (SOC) | 324 | 894 |
| Total, serious adverse events | Serelaxin + Standard of Care | 214 | 1,729 |
| Total, serious adverse events | Standard of Care (SOC) | 107 | 894 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Serelaxin + Standard of Care vs Standard of Care (SOC): deaths from any cause | Trial comparisons |
| Serelaxin + Standard of Care vs Standard of Care (SOC): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02064868
GET https://conductscience.org/api/trials/v1/NCT02064868/results?page=2